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Randomised clinical trial

Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C Dueck, Nancy Devlin, Hans-Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean-Francois Hamel, Madeleine King, Paul G Kluetz, Michael Koller, Daniel C Malone, Francesca Martinelli, Sandra A Mitchell, Carol M Moinpour, Jammbe Musoro, Daniel O'Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L Pimentel, Chantal Quinten, Jaap C Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M Soltys, Martin J B Taphoorn, Galina Velikova, Corneel Coens
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established...
October 18, 2016: Lancet Oncology
Yitao Zhang, Weijie Zeng, Shiyao Cheng, Zhichong Chen, Jiaojie Xue, Qing Wang, Maode Ou, Kanglin Cheng
BACKGROUND: Pulmonary hypertension (PH) is a serious disease, and treatment is a continuing challenge. Some in vitro and in vivo studies identified that statins were effective for PH. However, results of some randomised controlled trials (RCTs) have been controversial. The objective of our study was to clarify whether statins are effective and safe for pulmonary hypertension. METHODS: We systematically searched for eligible RCTs from PubMed, EMBASE, Web of Science, and the Cochrane Library during January 2016...
September 15, 2016: Heart, Lung & Circulation
Sarah A Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price
BACKGROUND: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities...
October 21, 2016: Trials
Allan Riis, Cathrine Elgaard Jensen, Flemming Bro, Helle Terkildsen Maindal, Karin Dam Petersen, Mette Dahl Bendtsen, Martin Bach Jensen
BACKGROUND: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). METHODS: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate...
October 21, 2016: Implementation Science: IS
Wouter van Ballegooijen, Jeroen Ruwaard, Eirini Karyotaki, David D Ebert, Johannes H Smit, Heleen Riper
BACKGROUND: Ecological momentary assessment (EMA) of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings...
October 21, 2016: BMC Psychiatry
M Aurich, D Albrecht, P Angele, C Becher, S Fickert, J Fritz, P E Müller, P Niemeyer, M Pietschmann, G Spahn, M Walther
Background: Osteochondral lesions (OCL) of the ankle are a common cause of ankle pain. Although the precise pathophysiology has not been fully elucidated, it can be assumed that a variety of factors are responsible, mainly including traumatic events such as ankle sprains. Advances in arthroscopy and imaging techniques, in particular magnetic resonance imaging (MRI), have improved the possibilities for the diagnosis of OCLs of the ankle. Moreover, these technologies aim at developing new classification systems and modern treatment strategies...
October 21, 2016: Zeitschrift Für Orthopädie und Unfallchirurgie
Marie Congiusta, Analia Veitz-Keenan
Data sourcesCochrane Oral Health group Trials Register, the Cochrane Central Register of Controlled Trials, Medline, US National Institutes of Health Trials Register, WHO-Clinical Trials Registry Platform for ongoing trials.Study selectionOnly randomised and quasi-randomised studies were pursued. No restrictions were placed on language or date of publication. The primary outcome sought was treatment success (complete healing or incomplete healing), uncertain healing and failure after one year of treatment, between one and four years and more than four years after treatment...
September 2016: Evidence-based Dentistry
Eileen Hoskin, Analia Veitz-Keenan
Data sourcesCochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Clinical and the WHO International Clinical Trials Registry Platform. There were no language restrictions.Study selectionRandomised controlled trials which compared the relief of pain with systemic antibiotics and analgesics against placebo and analgesics in the preoperative phase of irreversible pulpitis. The primary interest was pain control with an antibiotic or without one in the presence of analgesics...
September 2016: Evidence-based Dentistry
Kelvin I Afrashtehfar, Cyrus Dm Afrashtehfar
Data sourcesPubMed, Ovid, EMBASE and LILACS were searched up to December 2011. In addition, the reference lists of the selected review papers were further hand searched. Language was limited to studies published only in English.Study selectionHuman and animal randomised clinical trials (RCT), systematic reviews of RCTs, non-randomised trials, case series that reported on the clinical, radiographic, and/or histological outcomes of dental/oral implants exposed to excessive load were considered eligible for inclusion...
September 2016: Evidence-based Dentistry
Anne M Murray, Fang-Chi Hsu, Jeff D Williamson, R Nick Bryan, Hertzel C Gerstein, Mark D Sullivan, Michael E Miller, Iris Leng, Laura L Lovato, Lenore J Launer
AIMS/HYPOTHESIS: The Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, a double 2x2 factorial parallel-group randomised clinical trial, tested whether intensive compared with standard management of hyperglycaemia, BP or lipid levels reduced cognitive decline and brain atrophy in 2977 people with type 2 diabetes. We describe the results of the observational extension study, ACCORDION MIND ( registration no. NCT00182910), which aimed to measure the long-term effects of the three ACCORD interventions on cognitive and brain structure outcomes approximately 4 years after the trial ended...
October 20, 2016: Diabetologia
Annabelle South, Wendy R Parulekar, Matthew R Sydes, Bingshu E Chen, Mahesh K Parmar, Noel Clarke, Padraig Warde, Malcolm Mason
BACKGROUND: Recent trials have shown that the addition of external beam radiotherapy (EBRT) to androgen deprivation therapy (ADT) improves survival among men with locally advanced prostate cancer. OBJECTIVE: To examine the potential impact of these trials on changes in clinical practice and life-years saved. DESIGN SETTING AND PARTICIPANTS: A model was developed to examine the impact of changes in clinical practice in the UK. A survey of clinicians who treat men with prostate cancer in the UK and Canada was performed...
August 2016: European Urology Focus
C Huxley, J Achten, M L Costa, F Griffiths, X L Griffin
OBJECTIVES: The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority...
October 2016: Bone & Joint Research
Linda Garton, Amalie Dyda, Rebecca Guy, Bronwyn Silver, Skye McGregor, Belinda Hengel, Alice Rumbold, Debbie Taylor-Thomson, Janet Knox, Lisa Maher, John Kaldor, James Ward
Background: Extremely high rates of diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) have been recorded in remote communities across northern and central Australia. Re-testing at 3 months, after treatment administered, of CT or NG is recommended to detect repeat infections and prevent morbidity and ongoing transmission. Methods: Baseline CT and NG laboratory data (2009-2010) from 65 remote health services participating in a cluster randomised trial was used to calculate the proportion of individuals re-tested after an initial CT or NG diagnosis at <2 months (not recommended), 2-4 months (recommended) and 5-12 months and the proportion with repeat positivity on re-test...
October 21, 2016: Sexual Health
Steffen T Simon, Irene J Higginson, Sara Booth, Richard Harding, Vera Weingärtner, Claudia Bausewein
BACKGROUND: This is an updated version of the original Cochrane review published in Issue 1, 2010, on 'Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults'. Breathlessness is one of the most common symptoms experienced in the advanced stages of malignant and non-malignant disease. Benzodiazepines are widely used for the relief of breathlessness in advanced diseases and are regularly recommended in the literature. At the time of the previously published Cochrane review, there was no evidence for a beneficial effect of benzodiazepines for the relief of breathlessness in people with advanced cancer and chronic obstructive pulmonary disease (COPD)...
October 20, 2016: Cochrane Database of Systematic Reviews
Lauren E Arthur, Russell S Kizor, Adrian G Selim, Mieke L van Driel, Leonardo Seoane
BACKGROUND: Ventilator-associated pneumonia (VAP) is a significant cause of morbidity and mortality, complicating the medical course of approximately 10% of mechanically-ventilated patients, with an estimated attributable mortality of 13%. To treat VAP empirically, the American Thoracic Society currently recommends antibiotic therapy based on the patients' risk of colonisation by an organism with multidrug resistance. The selection of initial antibiotic therapy in VAP is important, as inappropriate initial antimicrobial treatment is associated with higher mortality and longer hospital stay in intensive care unit (ICU) patients...
October 20, 2016: Cochrane Database of Systematic Reviews
Elisa Bruno, Alessandra Nicoletti, Graziella Quattrocchi, Graziella Filippini, Carlo Colosimo, Mario Zappia
BACKGROUND: Essential tremor is one of the most common movement disorders. Treatment primarily consists of pharmacological agents. While primidone and propranolol are well-established treatments in clinical practice, they may be ineffective in 25% to 55% of patients and can produce serious adverse events in a large percentage of them. For these reasons, it is worth evaluating the treatment alternatives for essential tremor. Some specialists have suggested that pregabalin could be a potentially useful agent, but there is uncertainty about its efficacy and safety...
October 20, 2016: Cochrane Database of Systematic Reviews
Rafael E Pedro, Débora A Guariglia, Sidney B Peres, Solange M Moraes
BACKGROUND: Human immunodeficiency virus-associated lipodystrophy syndrome (HALS) is a major problem among people living with HIV/aids. The exercise training has been used for its treatment; however, the knowledge about benefits and safety still is emerging. The aim was systematically review the literature for physiological, metabolic, immunologic, and morphologic adaptations to aerobic, resistance, and concurrent training in people living with HALS. METHODS: A search of the Medline, Embase, Cinahl, Lilacs, Scielo, Web of Science, the Cochrane Controlled Trials Register Library and PEDro was performed...
October 20, 2016: Journal of Sports Medicine and Physical Fitness
Rupert M Pearse, Tom E Abbott, Richard Haslop, Tahania Ahmad, Brennan C Kahan, Claudia Filipini, Andrew Rhodes, Marco Ranieri
BACKGROUND: Over 300 million patients undergo surgery worldwide each year. Postoperative morbidity - particularly respiratory complications - are most frequent and severe among high-risk patients undergoing major abdominal surgery. However, standard treatments, like physiotherapy or supplemental oxygen, often fail to prevent these. Preliminary research suggests that prophylactic continuous positive airways pressure (CPAP) can reduce the risk of postoperative respiratory complications...
October 20, 2016: Minerva Anestesiologica
Pelin Üstüner, Ali Balevi, Mustafa Özdemir
INTRODUCTION: There is no satisfactory and efficient method for long-term removal of white-colored and thin hair. METHODS: We conducted a randomised clinical trial of hirsute patients with excessive white and/or thin hair on the face and/or axilla. In Group I (n: 16), the facial hair on one side of the face was painted with a black eyelash mascara immediately before Nd:YAG laser and the other half was only treated by Nd:YAG. In Group II (n: 20), the axillary hair on one side was painted with the mascara before the Alexandrite laser with the other side being only treated by Alexandrite...
October 20, 2016: Journal of Cosmetic and Laser Therapy: Official Publication of the European Society for Laser Dermatology
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